Policy Positions

February 25, 2016

Weighing the Impact of FDA Regulatory Uncertainty on Clinical Decision Support Development

Clinical decision support (“CDS”) software is not getting the regulatory clarity it needs and deserves. Although the United States Food & Drug Administration (“FDA”) made CDS software guidance an “A-list” priority in its 2015 regulatory agenda, the Agency has yet to define the portion of CDS software it intends to regulate and, for that portion it does regulate, the appropriate regulatory pathway to market.

Of course, developing a regulatory framework for CDS software is no easy task, as FDA must strike a delicate balance between ensuring patient safety and promoting innovation. However, until a regulatory approach is defined, CDS innovators will be left in the dark with regard to the expected costs and timelines for CDS development. Such uncertainty has already contributed to delays in CDS products reaching the market and, worse yet, the abandonment of CDS development projects altogether.

In fact, in a recent survey of CDS developers, nearly two thirds reported encountering delays due to regulatory uncertainty, and one third reported that regulatory uncertainty caused them to abandon development of a CDS product. Without clear regulatory guidance on which CDS products will be regulated and, for those that are, how such products will be regulated, valuable CDS tools, which can improve health outcomes, enhance the quality and consistency of care, and increase efficiency, will be kept out of the hands of clinicians and patients.

Download the full white paper here.

December 3, 2015

CDS Coalition Pharmaceutical Use Cases

There are several types of decisions in relation to the proper use of pharmaceuticals that standalone software can support:

  1. Is the patient a candidate for the drug, and will the patient likely respond to the drug?
  2. How can I select a particular drug from an approved class of drugs with the same mechanism of action?
  3. What is the evolving post-marketing safety profile of the drug and how can I select/change therapy based on this information?
  4. How should the drug be administered, including dosage calculations?

The CDS Coalition is dedicated to clarifying the FDA oversight of all clinical decision support software, including that which is used to support decision-making around the use of pharmaceuticals. As a result, the coalition is vitally interested in how FDA regulates, if at all, CDS used for those purposes.

For the list of case studies, CDS Coalition Pharmaceutical Use Cases.

August 7, 2015

CDS Use Cases

July 15, 2015

The goal of this document is to put together a list of example CDS use cases, together with the appropriate regulatory status for each, to evaluate FDA and congressional proposals to determine if they achieve appropriate results. Of course, any policy proposal from FDA or Congress needs to be written broadly enough to anticipate future new use cases, but this document can be a starting point to evaluate federal policy initiatives.

For the list of examples, CDS Use Cases.

August 7, 2015

CDS Coalition Proposal for an HIT-Type Medical Devices Master Classification Plan

July 8, 2015

Classification is the language of medical device regulation. For software that meets the statutory definition of a medical device and therefore is subject to FDA regulation, the starting point for any regulatory analysis is the determination of the classification in which the software fits.

For the full proposal, CDS Classification Proposal Final.

February 18, 2014

8 types of medical apps a Senate bill asks FDA to stop regulating

Bradley Merrill Thompson’s, one of the general counsels for the CDS Regulatory Coalition, examples of the types of apps that the PROTECT Act would instruct the FDA to stop regulating were featured in a mobihealthnews article here: http://mobihealthnews.com/29895/8-types-of-medical-apps-a-senate-bill-asks-fda-to-stop-regulating/. The examples were also featured in a Fierce Mobile Healthcare article available here: http://www.fiercemobilehealthcare.com/story/protect-act-would-deregulate-high-risk-cds-mobile-medical-apps/2014-02-13.

January 31, 2014

CDS Coalition: SOFTWARE Act goes too far

The Clinical Decision Support (CDS) Coalition charges that a bipartisan bill introduced in October 2013 to amend the Federal Food, Drug, and Cosmetic Act “goes too far” in deregulating CDS software that requires regulation to ensure the health and safety of patients. Read more on the Coalition’s legislative proposal here: http://www.fiercemobilehealthcare.com/story/cds-coalition-software-act-goes-too-far/2014-01-31?utm_medium=nl&utm_source=internal.

September 24, 2013

Statement by Bradley Merrill Thompson, General Counsel, mHealth Regulatory Coalition, on the Food and Drug Administration’s Final Guidance for Mobile Medical Application Developers

Statement by Bradley Merrill Thompson, General Counsel, mHealth Regulatory Coalition, on the Food and Drug Administration’s Final Guidance for Mobile Medical Application Developers 

Mr. Thompson is a well-known and respected expert on issues related to FDA regulation of medical technologies.  He is available for comment on the FDA final guidance on mobile medical technologies and other developing FDA issues. 

We applaud the U.S. Food and Drug Administration for issuing guidance that will illuminate a pathway for developers of mobile health applications.  This final guidance brings greater clarity to one of the most vibrant sectors of health care innovation and will serve as a catalyst for more rapid development of apps that are redefining American medicine.

There are two aspects of the FDA’s final guidance that are particularly praiseworthy.  First, the agency has drawn a clear line of separation between mobile applications that pose minimal, if any, risk to consumers and those that are integral to health care diagnosis and delivery by medical professionals.  By essentially deregulating many of the health-related apps that can transform smartphones into wellness devices, the FDA has performed a tremendous service for patients and consumers.

Also, the FDA has recognized the fast-moving nature of the mobile application industry and has created a guiding mechanism that is not static, but that allows adaptability to innovation.  It is significant that the agency is creating a dynamic webpage to see real-time comments and questions about the regulatory approach to mobile applications.  It is encouraging, to say the least, that a federal agency sees the importance of flexibility in working with a technological sector that is in a state of constant evolution.

There are still questions, of course, as to how the FDA will oversee mobile applications that have, in its determinations, the potential for greater risk.  For now, though, this guidance shows a genuine desire on the part of regulators to be advocates for innovation and health care transformation.

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